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ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector for testing female Luer Connectors for leakage
Escape Clause:
ISO 80369-7; Page 24; Annex C; Figure C.2; Note 2 states:
The minimum length of the female taper of 10,5 mm is required for
testing non-interconnectable characteristics. A minimum length of
the female taper of 7,5 mm may be used for the performance tests of
Clause 6.
What they are saying here is that if you use an ISO 594/1 Fig 5
Reference Fitting with a certified length of 7.5mm minimum you can
use it for all of the tests of ISO 80369-7 Paragraph/Clause 6, but
if you sent that Reference fitting out to be certified to match ISO
80369-7 Fig C.2 it will fail because it does not meet the 10.5mm
minimum. This escape Clause will allow you to use your old ISO
594/1 Fig 5 Reference Fittings until they wear out or until you
cannot convince the oversight party that it is allowed.
From our perspective:
If you request a quote for a new ISO 594/1 Fig 5 Reference
Connector from us; we will quote an item which will pass both ISO
594 and ISO 80369-7 requirements. It will be DUO-marked and
DUO-certified to both specifications.
ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector
The ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector is used
for testing Female Luer Connectors for: Leakage; Separation from
axial load; Stress cracking; and Non-interconnectable
characteristics in the ISO 80369-7; Clause 6 specified tests.
Keeping with the requirements of ISO 80369-7; the Reference
Connectors we sell are from hardened stainless steel. The ISO
80369-7 Fig C.2 Male Reference Luer Slip Connector has design
details which are not specified in ISO 80369-7 and which allow
connection to test equipment. These design details vary by
manufacturer so be sure you understand the configuration before you
order the Reference Connector. The ISO 80369-7 Fig C2 Male
Reference Luer Slip Connector is an integral part of Luer needle
and syringe testing.
Uses for the ISO 80369-7; Page 24; Annex C; Fig C.2; Male Reference
Luer Slip Connector
Below is a list of tests which are best accomplished by using the
ISO 80369-7 Fig C.4 Male Reference Luer Slip Connector:
ISO 80369-7 Clause...
4.1: Non-Interconnectivity
6.1: Fluid Leakage
6.2: Sub-Atmospheric Pressure Air Leakage
6.3: Stress Cracking
6.4: Resistance To Separation From Axial Load